Drive the clinical development strategies and protocols
including all phases of clinical development programs in oncology areas.
Key domains include study synopsis/protocols development, ,
medical review to identify potential safety risk and efficacy signals, and
completion of clinical study reports by working with CRO staff. Guide CRO staff
with medical related service to ensure clinical data integrity and quality and
provide full medical support to IND and NDA application globally.
Interact externally with investigators for medical
communications and investigators engagement; and interact with key global
regulatory authorities by request.
Work cross-functionally to ensure projects coordinated
partners from multiple departments including preclinical pharmacology and
toxicology, CMC, project management, health economics, regulatory, , and
a visionary leader and mentor of a clinical team and CROs worldwide.
MD or equivalent doctoral degree preferably with focus in Oncology area.
Overseas medical training is a plus.
writing and presentation skills in both English and Chinese.
leadership and collaborative interpersonal skills.
10 years of experience in the bio-pharmaceuticals. Multinational national
company experience is preferred.The
experiences in the Oncology study design and regulatory requirements is
required. The responsibilities of this position include also the medical monitoring
the trials and reviewing trial data and handling safety related issues.
with successful IND/NDA submissions and approvals and interactions with
regulatory agencies is highly desired.
to work with a multi-disciplinary team, prioritize tasks efficiently and
deliver results timely.
to perform thorough reviews of various medical and legal documents in a timely
Work independently and
think widely as a leader, self-motivated, fast-learner, willing to meet
challenges and share responsibilities with partners.
We offer you an open
biotech culture, an exciting journey throughout the world of drug clinical
research and development. You can expect to work with a successful,
highly-qualified and dynamic team as you develop your individual scientific and
management skills, and entrepreneur competency. You can also look forward to a
flexible working environment, a pleasant and homelike atmosphere as well as
competitive incentive package. If you are looking for a big stage for your
profession or beyond, if you are willing to walk out of your “comfortable zone”
in your career, come and join us!